Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement

Phase 3 Completed 8 enrolled Mount Sinai Hospital, Canada

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this feasibility clinical trial is to explore the role of intranasal fentanyl for pain associated with PICC placement in preterm infants. The primary goals are identifying whether enough infants join the study and complete the study procedures.

Timeline

Start: 2024-08-09
Primary completion: 2025-02-09
Completion: 2025-02-09

Outcome

Mixed primary results

paper The target recruitment of 24 participants was not achieved. PMID 41007021 ↗

paper all video-recordings were suitable for pain assessment by outcome assessors with a success rate of 100% (95% CI 61, 100). PMID 41007021 ↗

Publications

Tabbara N, McLeod SL, Taddio A, Shah V. Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): A Feasibility Randomized Controlled Trial. Children (Basel). 2025 Aug 30;12(9):1156. doi: 10.3390/children12091156.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	1.5 ug/kg	Intranasal

Indications

No indication recorded.